Manufacturer registered with FDA
Kohler Medizintechnik GmbH
STOCKACH, Germany. Lists 46 dental device types with FDA across 1 registered establishment.
- Device types listed
- 46
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7265 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name Kohler Medizintechnik GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Kohler Medizintechnik GmbH | 46 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | Kohler Medizintechnik GmbH | 231 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Kohler Medizintechnik GmbH | 27 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Kohler Medizintechnik GmbH | 4 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | KOHLER MEDIZINTECHNIK GMBH | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kohler Medizintechnik GmbH | 1 | 2013–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Kohler Medizintechnik GmbH | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Kohler Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Kohler Medizintechnik GmbHFDA reg. 8010732 | STOCKACH Baden-Wurttemberg, Germany | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010732). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.